{
  "FullStudy":{
    "Rank":218174,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01511770",
          "OrgStudyIdInfo":{
            "OrgStudyId":"AA01660"
          },
          "Organization":{
            "OrgFullName":"Dr. Reddy's Laboratories Limited",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"Bioavailability Study of Fluconazole Tablets 200 mg Under Fasting Conditions",
          "OfficialTitle":"Comparative,Randomized,Single-dose,2-way Crossover Bioavailability Study of Dr.Reddy's Laboratories Limited Fluconazole Tablets 200 mg and PFIZER (DIFLUCAN) 200 MG in Healthy Males Under Fasting Condition."
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2012",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"August 2002"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"August 2002",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"September 2002",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 13, 2012",
          "StudyFirstSubmitQCDate":"January 18, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 19, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 18, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 19, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Dr. Reddy's Laboratories Limited",
            "LeadSponsorClass":"INDUSTRY"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The objective of this study was an open-label, randomized, 2-way crossover to compare the single-dose relative bioavailability of Dr. Reddy's Laboratories, Ltd. and Pfizer (Diflucan®) 200 mg fluconazole tablets under fasting conditions.",
          "DetailedDescription":"Detailed Description : The study was conducted as an open-label, randomized, single-dose, 2-way crossover, relative bioavailability study performed on 18 healthy adult male volunteers. A total of 17 subjects completed the clinical phase of the study. In each period, subjects were housed from the morning dosing until after the 72-hour blood draw. Single oral 200 mg doses were separated by a washout period of 21 days."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Healthy"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Bioequivalence",
              "Fluconazole",
              "Crossover"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 1"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Crossover Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"17",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Fluconazole",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Fluconazole Tablets 200 mg of Dr. Reddy's Laboratories limited.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Fluconazole"
                  ]
                }
              },{
                "ArmGroupLabel":"Diflucan",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"Diflucan 200 mg fluconazole tablets of Pfizer",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Fluconazole"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"Fluconazole",
                "InterventionDescription":"Fluconazole Tablets, 200 mg",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Fluconazole"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "Dr. Reddy's Laboratories"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"Fluconazole",
                "InterventionDescription":"Fluconazole 200 mg tablets",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Diflucan"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "Diflucan (Pfizer)"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Area Under Curve (AUC)",
                "PrimaryOutcomeTimeFrame":"pre dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5,4, 6, 9, 12, 24, 48 and 72 hours post-dose."
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nExclusion Criteria:\n\nHistory or presence of significant:\n\n• cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease.\n\nIn addition, history or presence of:\n\nalcoholism or drug abuse within the past year;\nhypersensitivity or idiosyncratic reaction to fluconazole or other azoles. Subjects who have used any drugs or other substances known to be strong inhibitors of CYP (cytochrome P450) enzymes within 10 days prior to first dose.\n\nSubjects who have used any drugs or other substances known to be strong inducers of CYP (cytochrome P450) enzymes within 28 days prior to first dose.\n\nSubjects who have been on an abnormal diet (for whatever reason) during the 28 days prior to the first dosing.\n\nSubjects who, through completion of the study, would have donated in excess of:\n\n500 mL of blood in 14 days, or\n500 - 750 mL of blood in 14 days (unless approved by the Principal Investigator),\n1000 mL of blood in 90 days,\n1250 mL of blood in 120 days,\n1500 mL of blood in 180 days,\n2000 mL of blood in 270 days,\n2500 mL of blood in 1 year. Subjects who have participated in another clinical trial within 28 days prior to the first dosing.",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"Male",
          "MinimumAge":"18 Years",
          "MaximumAge":"45 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Gaetano Morelli, MD",
                "OverallOfficialAffiliation":"MDS Pharma Services",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"MDS Pharma Services",
                "LocationCity":"Cohen street, saint-laurent, montreal (quebec)",
                "LocationZip":"H4R 2N6",
                "LocationCountry":"Canada"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000015725",
                "InterventionMeshTerm":"Fluconazole"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000000935",
                "InterventionAncestorTerm":"Antifungal Agents"
              },{
                "InterventionAncestorId":"D000000890",
                "InterventionAncestorTerm":"Anti-Infective Agents"
              },{
                "InterventionAncestorId":"D000058888",
                "InterventionAncestorTerm":"14-alpha Demethylase Inhibitors"
              },{
                "InterventionAncestorId":"D000065607",
                "InterventionAncestorTerm":"Cytochrome P-450 Enzyme Inhibitors"
              },{
                "InterventionAncestorId":"D000004791",
                "InterventionAncestorTerm":"Enzyme Inhibitors"
              },{
                "InterventionAncestorId":"D000045504",
                "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action"
              },{
                "InterventionAncestorId":"D000065088",
                "InterventionAncestorTerm":"Steroid Synthesis Inhibitors"
              },{
                "InterventionAncestorId":"D000006727",
                "InterventionAncestorTerm":"Hormone Antagonists"
              },{
                "InterventionAncestorId":"D000006730",
                "InterventionAncestorTerm":"Hormones, Hormone Substitutes, and Hormone Antagonists"
              },{
                "InterventionAncestorId":"D000045505",
                "InterventionAncestorTerm":"Physiological Effects of Drugs"
              },{
                "InterventionAncestorId":"D000065688",
                "InterventionAncestorTerm":"Cytochrome P-450 CYP2C9 Inhibitors"
              },{
                "InterventionAncestorId":"D000065689",
                "InterventionAncestorTerm":"Cytochrome P-450 CYP2C19 Inhibitors"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M16879",
                "InterventionBrowseLeafName":"Fluconazole",
                "InterventionBrowseLeafAsFound":"Fluconazole",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M2835",
                "InterventionBrowseLeafName":"Antifungal Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M4835",
                "InterventionBrowseLeafName":"Clotrimazole",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M10379",
                "InterventionBrowseLeafName":"Miconazole",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M2795",
                "InterventionBrowseLeafName":"Anti-Infective Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M29124",
                "InterventionBrowseLeafName":"Cytochrome P-450 Enzyme Inhibitors",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M8372",
                "InterventionBrowseLeafName":"Hormones",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M8371",
                "InterventionBrowseLeafName":"Hormone Antagonists",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"Infe",
                "InterventionBrowseBranchName":"Anti-Infective Agents"
              },{
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              }
            ]
          }
        }
      }
    }
  }
}